MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXPLUS PRESSURE RATED EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MP5305-C
Medical Device Problem Codes	Nonstandard Device (1420); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxplus pressure rated extension set was occluded.The following information was received by the initial reporter with the following verbatim.It was reported by customer that we attach a saline flush to the extension set to flush saline through the line before attaching to the patient's iv catheter.The saline will not flush through the tube at all.We even tried detaching everything from the tube itself and nothing will flush through.After further investigation, the tube itself has not been hollowed out.There is still a section where the tubing is completely closed.
Additional Manufacturer Narrative
The customer reported the line would not flush at all, and returned a video of the issue, of material mp5305-c, lot 24079533.Upon initial visual examination, the video confirmed the complaint of flow issues - fluid blockage.The video also showed that the tubing had a block within the fluid path, near the male luer.This is evidence of excess solvent applied during assembly.The manufacturing plant found the root cause for the occlusion to be related to incorrect solvent application during assembly process.The plant did not take any actions to address the failure as the line for material mp5305-c was reactivated at a different bd plant, starting march 10th, 2025.The plant that produced this batch is no longer producing the material number.The plants are in communication regarding all quality issues during the changeover.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23001353
• Report Number: 9616066-2025-02692
• Device Sequence Number: 12970050
• Product Code: FPA
• UDI-Device Identifier: 10885403236679
• UDI-Public: (01)10885403236679(17)270731(10)24079533
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: MP5305-C
• Device Lot Number: 24079533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown